Two consumer groups have sued the Food and Drug Administration (FDA) seeking to compel the agency to implement the traceability provisions in the FDA Food Safety Modernization Act (FSMA). Specifically, the plaintiffs want FDA to meet its obligation under FSMA to establish and publish a list of high-risk foods and engage in rulemaking setting forth additional traceability record keeping requirements for facilities that manufacture, process, pack, or hold those foods. The lawsuit was brought in the U.S. District Court for the Northern District of California by the Center for  Food Safety (CFS) and Center for Environmental Health (CEH).

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As a reminder, the Food and Drug Administration (FDA) requires all registered food facilities to renew their registration biennially in each even-numbered year. The current renewal period began October 1, 2018, and runs through 11:59 p.m. on December 31, 2018. Even if you have already registered or updated a facility registration in the last year, you are still required to renew the facility’s registration during this renewal period. If a facility fails to renew its registration, the registration is considered expired and will be removed by FDA.

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Last week, the California Office of Environmental Health Hazard Assessment (OEHHA), the lead agency that implements California’s Proposition 65, proposed an amendment to the existing regulation requiring: (1) the average concentration of a listed chemical as causing reproductive toxicity (e.g., lead) be based on products from the same manufacturing facility; and (2) the dietary exposure to a listed chemical as causing reproductive toxicity be calculated using the arithmetic mean. If adopted, the proposed changes would overrule the court decision in Environmental Law Foundation v Beechnut Nutrition Corp on how to determine the daily intake of listed chemicals as causing reproductive toxicity. The change could impose additional testing requirements on the industry and could create a more rigid standard for falling within a safe harbor. We encourage food companies to evaluate whether the proposed changes would adversely impact their current Proposition 65 compliance positions.

Comments to the proposed regulation are due by November 19, 2018. In addition, a public hearing on the proposed amendment would be scheduled on request. To request a hearing, OEHHA needs to be notified no later than November 5, 2018.

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The Food and Drug Administration recently issued a request for information on the use of the names of dairy foods in the labeling of plant-based products. This action arose from the agency’s Nutrition Innovation Strategy, one tenet of which is a focus on modernizing food standards. During Commissioner Gottlieb’s remarks at the Nutrition Innovation Strategy public meeting, he stated that requests for the agency to take a closer look at the dairy standards of identity is one of many reasons why FDA is interested in modernizing the food standards, and that this would be the first area in which FDA is going to have an active public process for reviewing the standards and how consumers understand the use of terms like “milk” on both animal-derived and plant-based products.

This RFI aims to gather information on how consumers use plant-based products and how consumers understand the use of dairy terms, such as “milk,” or “yogurt” when they appear on the labels of plant-based products, as well as the nutritional attributes of these products and how these products can help consumers meet the recommendations in the Dietary Guidelines for Americans.

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On September 26, 2018, the Food and Drug Administration issued a statement by FDA Commissioner Scott Gottlieb, M.D. on FDA’s commitment to disclose retailer information for certain food recalls to improve consumer safety. Additionally, on September 27, 2018, FDA published a Federal Register Notice announcing availability of a draft guidance on the Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls. Publication of the Draft Guidance is the second of a series of policy steps the agency is taking as part of a broader plan to improve oversight of food safety and the recall process.

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The U.S. Food and Drug Administration (FDA) recently announced that it will engage in a pilot program to evaluate the benefits of two-tier inspections for some aspects of the Preventive Controls for Human Food (PCHF) rule under the FDA Food Safety Modernization Act (FSMA). Through a Notice to Industry, FDA is inviting food companies with multiple facilities that implement centrally developed supply-chain programs and recall plans to apply to participate in two-tier inspections. FDA plans to limit initial participation in the program to five businesses. FDA will consider the results of the two-tier inspections pilot to determine the feasibility of employing the two-tier approach to inspections on a broader scale. This post summarizes the program and FDA’s criteria for participation. Interested companies must notify FDA of their desire to participate no later than October 31, 2018.

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In the final batch of technical notices, the UK Government has provided guidance on what impact traders can expect on food labelling and packaging in the event that the UK exits the EU without a Withdrawal Agreement on 29 March 2019.

Currently, EU rules, such as EU Regulation 1169/2011 or “FIC”, govern food labelling and minimum compositional standards (with some exceptions) for foods in the UK. As explained in a previous blog, from 29 March 2019, these EU-based rules will be absorbed into English law as part of the Withdrawal Act and adapted where necessary by way of statutory instruments to ensure they apply as intended. There will however be a number of additional changes required to food labels to reflect the fact that the UK will no longer be a member of the EU.

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On August 1, 2018, two consumer groups sued the U.S. Department of Agriculture (USDA), USDA Secretary Sonny Perdue, and Agricultural Marketing Service (AMS) Administrator Bruce Summers for failing to meet the statutory rulemaking deadlines for the National Bioengineered Food Disclosure Standard (NBFDS). The suit was filed by the Center for Food Safety (CFS) and Center for Environmental Health in the United States District Court for the Northern District of California. 1/ On September 6, 2018, the plaintiffs filed a motion for summary judgment requesting that the court order USDA to issue the rule within 60 days.

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The Food and Drug Administration (“FDA” or “the agency”) recently issued a proposed rule that will ease the Freedom of Information Act (“FOIA”) request process for certain records within FDA’s possession. The proposed rule would amend FDA’s regulations to reflect updated Federal requirements for information access, clarify certain provisions of FDA’s information access regulations, and make the FOIA process easier for the public to navigate. The agency anticipates that these changes, taken together, will enhance transparency for the public with regard to FDA activities.

FOIA is a law that gives the public the right to access information from the Federal government. There is a presumption that government records must be released under FOIA unless they are subject to an exemption. In this regard, FDA is proposing to amend its regulations to state explicitly that the agency would withhold information under FOIA only if the agency reasonably foresees that disclosure would harm an interest protected by an exemption or disclosure is prohibited by law.

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The U.S. Food and Drug Administration (FDA) recently issued two guidance documents to assist establishments in determining whether they have an obligation to register as a food facility. The first document is the finalized seventh edition of FDA’s Questions and Answers Regarding Food Facility Registration (Final Guidance). The second document is a supplemental draft guidance to the seventh edition (Supplemental Draft Guidance), which addresses which parties must register in situations where multiple entities share a physical space (e.g., a food manufacturer leases a building). The Supplemental Draft Guidance is open for comments through October 19, 2018. This memorandum summarizes the changes made in the Final Guidance since it was originally proposed in draft form in December 2016 and the new content in the Supplemental Draft Guidance.

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